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FDA 510(k)

QUANTIEN Measurement System

K-Number: K172182 · 2017-08-18

ApplicantSt. Jude Medical (Now Part of the Abbott Medical)
Decision Date2017-08-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIEN Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K172182. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIEN Measurement System?

QUANTIEN Measurement System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). The 510(k) number is K172182.

When did QUANTIEN Measurement System receive FDA 510(k) clearance?

QUANTIEN Measurement System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172182.

Who is the listed applicant for QUANTIEN Measurement System?

The FDA 510(k) record lists St. Jude Medical (Now Part of the Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIEN Measurement System?

The FDA product code for QUANTIEN Measurement System is DQK.

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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